Implantable Medical Electrical Device Connector Module Assemblies and Methods

ABSTRACT

Methods for forming an insulative body of an implantable medical device connector module assembly employ an injection molding process, whereby first and second shots of insulative material form core and an overlay portions, respectively. In some methods, a panel portion of an electrical component is mounted between opposing surfaces of a mold such that a finger-like portion of the component extends into a cavity of the mold, with a first side thereof touching another surface of the mold and a second, opposite side exposed within the cavity; following first shot injection, the core portion captures the finger-like portion in relatively rigid relation thereto. When two types of connector bores are formed, a color indicator may be engaged with a feature of the core portion that is located in proximity to a connector bore of the first type, and then the overlay portion is formed over the indicator.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is related to the co-pending andcommonly-assigned U.S. Patent Application, filed concurrently herewith,that has the Atty. Docket No. C00001179.USU1, and is entitled CONNECTORMODULE ASSEMBLIES, METHODS, AND COMPONENTS FOR IMPLANTABLE MEDICALELECTRICAL DEVICES.

FIELD OF THE DISCLOSURE

The present invention pertains to implantable medical devices, and, moreparticularly to connector module assemblies thereof.

BACKGROUND

Implantable medical systems that are designed to deliver electricalstimulation, for example, to cardiac muscle or the spinal cord, and/orto monitor bodily electrical activity, typically include a relativelycompact implantable device, for example, like an exemplary device 100shown in FIG. 1, and one or more elongate implantable electrical leads(not shown). With reference to FIG. 1, those skilled in the art willappreciate that three connector terminals of one or more leads may beplugged into bores 121, 122 of a connector module assembly 115 of device100, to electrically couple electrodes of the one or more leads to apower source and circuitry which is contained in a hermitically sealedhousing 104, for example, formed from a Titanium alloy, on whichconnector module assembly 115 is mounted. Connector module assembly 115includes one or more contact surfaces exposed along a length of eachbore 121, 122 for electrical coupling with corresponding contactsurfaces of the corresponding lead connector terminal inserted therein.An insulative body of connector module assembly 115 supports andisolates the contact components and corresponding conductiveinterconnects that extend from the contact components to hermeticallysealed feedthroughs, within the insulative body, for electrical couplingof the contact components to the circuitry and power supply withinhousing 104. Numerous constructions and assembly methods for implantablemedical device connector module assemblies are known in the art, some ofwhich are disclosed in commonly assigned U.S. Pat. Nos. 6,895,276,7,309,262, 7,317,946, 7,526,339, 7,717,754 and 8,032,221. However, thereis still a need for new and improved connector module assemblyconstructions and associated assembly methods.

SUMMARY

Methods of the present invention employ at least a two-stage moldingprocess to form an insulative body of a medical device connector moduleassembly, such that the insulative body includes a core portion, formedby a first shot of insulative material, and an overlay portion, formedby a second shot of insulative material. According to some methods, afeedthrough interface panel portion of an electrical component of theconnector module assembly is mounted between opposing surfaces of a coremold so that an elongate finger-like portion of the mounted electricalcomponent extends into a cavity of the core mold with a first sidetouching another surface of the core mold and a second, opposite sideexposed within the cavity; and, following injection of the first shot ofinsulative material, the formed core portion of the insulative bodyextends over at least a portion of the second side of the elongatefinger-like portion of the electrical component to capture the elongatefinger-like portion in relatively rigid relation thereto. Thefinger-like portion of the electrical component may comprise an antennaor a contact interface, and more than one of such electrical componentsmay be mounted in the core mold for capture in the formed core portion.When the electrical component includes the contact interface, a contactcomponent, which is contained within the core portion, is coupled to thecontact interface. The contact component may be coupled to the contactinterface either before or after forming the core portion, dependingupon when the contact component is contained in the core portion.

The core portion, which may or may not contain a contact component, andthe one or more captured electrical components are preferably placed ina cavity of an overlay mold such that at least a portion of the firstside of each elongate finger-like portion is exposed in the cavity; and,following injection of the second shot of insulative material, theformed overlay portion of the insulative body extends over all or aportion of the first side of each elongate finger-like portion.According to some methods, if the aforementioned contact component isinserted into the core portion following the formation of the coreportion, and the elongate finger-like portion of the electricalcomponent comprises a contact interface, the contact interface touches asurface of a core pin that is positioned in the cavity of the core mold.Furthermore, coupling of the contact interface to the contact componentmay be accomplished after the overlay portion of the insulative body isformed, in which case, the overlay portion may be formed with anaperture providing access for the coupling.

Alternately, if the core portion is formed around the contact component,the contact interface is coupled to the contact component, which may bemounted on a core pin, prior to forming the core portion. When the coreportion of the insulative body is formed around a contact component thatincludes a flanged bore sized to create a shutoff with a pin of both thecore mold and the overlay mold, the flanged bore of the contactcomponent is positioned about the pin in the core mold, prior to formingthe core portion, and then about the pin in the overlay mold, prior toforming the overlay portion.

According to some embodiments and additional methods, when two types ofconnector bores are formed in the core portion of the insulative body ofthe connector module assembly, a color indicator is engaged with afeature of the core portion that is located in proximity to a connectorbore of the first type. The color indicator is engaged with the featureprior to forming the overlay portion, which extends thereover, and theoverlay portion is translucent for viewing the indicator therethrough.The feature of the core portion preferably extends about a perimeter ofthe connector bore of the first type; and the color indicator ispreferably engaged with the feature such that the indicator can beviewed from an angle that is approximately perpendicular to alongitudinal axis of the connector bore of the first type.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of thepresent invention and therefore do not limit the scope of the invention.The drawings are not to scale (unless so stated) and are intended foruse in conjunction with the explanations in the following detaileddescription. Embodiments will hereinafter be described in conjunctionwith the appended drawings wherein like numerals/letters denote likeelements, and:

FIG. 1 is a perspective view of an exemplary implantable medical deviceincluding a connector module assembly, which may be constructedaccording to some embodiments and methods of the present invention;

FIG. 2A is a perspective view of a welded assembly of components,according to some embodiments and methods;

FIGS. 2B-C are perspective views of molded assemblies for a connectormodule assembly, according to some methods and embodiments;

FIG. 3 is a perspective view of a contact component, according to someembodiments of the present invention;

FIG. 4A is a perspective view of a connector module assembly, accordingto some embodiments;

FIG. 4B is a section view along centerline B of FIG. 4A, according tosome embodiments;

FIG. 5 is a section view, similar to that shown in FIG. 4B, whereinsealing set screws are mated with contact components, according to someembodiments;

FIG. 6A is a flow chart outlining some methods of the present invention;

FIG. 6B is a flow chart outlining some additional methods;

FIG. 7A is a perspective view of contact components engaged with twotypes of pins, according to some methods of the present invention;

FIG. 7B is a perspective view of a portion of mold tooling in which thewelded assembly of components are placed for molding a core portion ofan insulative body of a connector module assembly, according to someembodiments and methods;

FIG. 7C is another perspective view, with cross-section, of the placedcomponents and portion of the mold tooling shown in FIG. 7B;

FIG. 7D shows two perspective views, with cross-sections, of a coreassembly placed in an overlay mold, according to some embodiments andmethods; and

FIG. 8 is a perspective view of a core assembly, according to someembodiments and methods.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration of theinvention in any way. Rather, the following description providespractical examples, and those skilled in the art will recognize thatsome of the examples may have suitable alternatives. Examples ofconstructions, materials, dimensions and fabrication processes areprovided for select elements and all other elements employ that which isknown by those skilled in the art.

FIG. 1 is a perspective view of implantable medical device 100 includingconnector module assembly 115, which may be constructed according tosome embodiments and methods of the present invention, for example, asintroduced by FIGS. 2A-C. According to some embodiments, connectormodule assembly 115 includes two types of connector bores, whereinconnector bore 121 corresponds to a first type of bore and each ofconnector bores 122 corresponds to a second type; an indicator or markermay be included in the construction of connector module assembly 115,according to some methods described below, to identify bore 121 as thefirst type. As mentioned above, each of bores 121, 122 is configured toreceive a connector terminal of an implantable medical electrical leadfor electrical coupling of the lead to the power source and circuitrycontained in housing 104.

FIG. 2A is a perspective view of a welded assembly that includeselectrical components 200, 270, set screw block (ssb) contact components230, and a multi-beam contact (mbc) component 210. FIG. 2A illustrateseach electrical component 200, 270 including a feedthrough interfacepanel portion 290, 297 and one or more elongate finger-like portions 20,23, 207 extending therefrom; wherein each elongate finger-like portion20, 23 of electrical component 200 includes a contact interface 220, 223coupled to a corresponding conductive trace (not shown) formed oninterface panel portion 290; and wherein elongate finger-like portion207 of component 270 forms an antenna. Antenna 207 is useful fortelemetry communications known in the art, for example, as described inthe above-referenced commonly assigned U.S. Pat. No. 7,317,946. FIG. 2Afurther illustrates each contact interface 220 coupled to acorresponding ssb contact component 230 or to mbc component 210, andeach contact interface 223 not yet coupled to a corresponding contactcomponent that will be described below. Those skilled in the art willappreciate that each contact component of connector module assembly 115has a connector bore, aligned with the corresponding bore 121, 122,within which electrical contact is made with a corresponding contactelement on an inserted lead connector terminal. Each feedthroughinterface panel portion 290, 270 is adapted for mounting to a sidewallof device housing 104 (FIG. 1) and for coupling to the aforementionedhermetically sealed feedthrough assembly (not shown), which may beconstructed according to embodiments and methods known in the art.

According to some methods of the present invention, which will bedescribed in greater detail below, an insulative body of connectormodule assembly 115 is molded around the welded assembly of FIG. 2A,preferably in two shots, or stages, for example, as illustrated in FIGS.2B-C. FIG. 2B illustrates a core assembly 26 including a first shot ofan insulative material, that forms a core portion 260 to partiallysurround and capture the welded assembly. The insulative material ispreferably a medical grade thermoplastic material, such as polyurethane,for example, having a durometer of between approximately 50 and 90 on ashore D scale. With reference to FIG. 2B, a side of each elongatefinger-like portion 20, 23, 207 is exposed, while core portion 260extends over an opposite side of each, to capture each portion 20, 23,207 in relatively rigid relation thereto. It should be noted that,according to some alternate methods, any or all of electrical component200, ssb contact components 230 and mbc contact component 210 may beintegrated, or assembled into core assembly 26 after core portion 260 isformed around electrical component 270 to capture antenna 207 inrelatively rigid relation thereto. FIG. 2C illustrates an overlayportion 280 formed by a second shot of insulative material, for example,the same thermoplastic material that forms core portion 260, that hasbeen molded around core assembly 26 to form an outer surface of theinsulative body of connector module assembly 115; the outer surface mayhave first, second, third and fourth faces 11, 12, 13, 14, as designatedin FIG. 2C.

According to the illustrated embodiment, overlay portion 280 extendsover the sides of finger-like portions 20, 23, 207 that were exposed incore assembly 26, yet, FIG. 2C illustrates each of a first set ofcontact interfaces 223 exposed through apertures 213 that are formedthrough third face 13 of overlay portion 280 of the insulative body,and, with reference to FIG. 2A, it should be understood that a secondset of contact interfaces 223 are exposed through similar aperturesformed through fourth face 14. According to the illustrated embodiment,a stack of contact components is inserted within each one of the lowertwo bores 122, such that a connector bore of each stack is approximatelycoaxial with the corresponding bore 122, for receipt of a correspondingmedical electrical lead terminal therein, and each contact component ofthe stack is aligned with a corresponding contact interface 223 forcoupling thereto, for example, by laser welding, through a correspondingaperture 213, after which, each aperture 213 is sealed off with aninsulative adhesive, for example, silicone medical adhesive. Connectormodule constructions including such stacks of contact components aredescribed in commonly assigned U.S. Pat. Nos. 6,895,276 and 7,717,754,which are hereby incorporated by reference. With further reference toFIGS. 2A-C, each of the stack contact components, ssb contact components230 and mbc component 210 include a connector bore, which is aligned andin fluid communication with the corresponding bore 121, 122, and eachcomponent connector bore has a corresponding contact surface forelectrical coupling with a contact surface of a corresponding medicalelectrical lead connector terminal that is received therein.

FIG. 3 is a perspective view of one of ssb contact components 230,according to some embodiments of the present invention. FIG. 3illustrates component 230 including a connector bore 320 and a threadedbore 340; connector bore 320 extends from an opening 351 at a first face31 thereof and has an interior contact surface 324, and threaded bore340 extends outward from connector bore 320 toward a second face 32 ofcomponent 230. Connector bore 320 preferably extends to another openingat a third face 33 of component 230, which is opposite first face 31.Threaded bore 340 is adapted to mate with a set screw so that aconductive end of the mating set screw is positioned within connectorbore 320, for example, like a conductive end 505 of a set screw 500shown in FIG. 5, which, when engaged as illustrated, forces an insertedlead connector terminal 50 into contact with contact surface 324.

FIG. 3 further illustrates a flanged bore 360 of ssb contact component230 in fluid communication with threaded bore 340 and extending out fromsecond face 32 to an opening 352. According to preferred embodiments ofthe present invention, flanged bore 360 has a relatively smoothperimeter surface 306 sized for a minimum slip-fit clearance fit arounda mold pin, to provide a shutoff therewith that prevents the insulativematerial from flowing into the threads of threaded bore 340, during amolding process to form the insulative body of the connector moduleassembly. Creating such a shutoff, between a perimeter surface offlanged bore 360 and the mold pin, is an improvement over the prior art,in which mold pins are configured to mate with the threaded bore ofssb-type contact components, and/or a particular alignment and pressureof a terminal face of the mold pin, against an internal shoulder of thecontact component, is critical to provide the necessary shutoff. Thus,it may be appreciated that the above-described flanged bore 360 ofcontact component 230 eliminates more time consuming and tediousprocesses that require threaded engagement with a mold pin and/or arepeatable alignment and pressure to provide shutoff during molding.Furthermore, prior art pins that engage with the threads of contactcomponents can make these threads more vulnerable to damage duringprocessing.

According to some preferred embodiments, a centerline axis of flangedbore 360 is aligned with a centerline axis B of threaded bore 340, forexample, to within approximately 0.002 inch (0.05 mm), so that, inaddition to creating the shutoff, flanged bore 360 locates an engagedmold pin to form an insulative bore thereabout that has a centerlineaxis aligned with axis B, for example, to within approximately 0.002inch (0.05 mm). With reference to FIGS. 4A-B, such an insulative bore422 is shown extending from flanged bore 360 of component 230, outwardto an opening 152 on a second face 12 of connector module assembly 115.FIGS. 4A-B illustrate insulative bore 422 having a perimeter surface 402that is flush with perimeter surface 306 of flanged bore 360. Withreference to FIG. 5, the preferred alignment of insulative bore 422 isadvantageous if perimeter surface 402 of insulative bore 422 forms asealing zone for a seal member 525 (i.e. silicone O-ring) of set screw500, when set screw 500 is engaged within threaded bore 340 andconductive end 505 is positioned within connector bore 320 to forceinserted lead terminal 50 into contact with conductive surface 324. FIG.5 further illustrates an insulative jacket 502 surrounding a head andneck of set screw 500, and the above-referenced commonly assigned U.S.Pat. No. 8,032,221 describes embodiments of sealing set screws similarto set screw 500.

FIGS. 4B and 5 further illustrate insulative bore including an optionalgroove 43 formed therein, in proximity to opening 152. According to theillustrated embodiment, optional groove 43 is sized to receive sealmember 525, in a relaxed state, when set screw 500 is retracted upthrough opening 152 and out of connector bore 320, and, thereby, retainsset screw 500, prior to positioning conductive end 505 within connectorbore 320. According to an exemplary embodiment, a length L of thatportion of insulative bore 422, which forms the sealing zone betweenoptional groove 43 and flanged bore 360 of ssb contact component 230, isbetween approximately 0.03 inch (0.76 mm) and approximately 0.05 inch(1.27 mm), preferably approximately 0.04 inch (1 mm). Flanged bore 360may have a depth d of between approximately 0.010 inch (0.25 mm) andapproximately 0.04 inch (1 mm), wherein the lower end of depth d islimited by the above-described shutoff function, and the upper end ofdepth d is limited by size constraints on connector module assembly 115,for example, such that insulative bore 422 has an adequate length forthe sealing zone and optional groove 43. It should be noted that,according to alternate embodiments, in lieu of the sealing zone, formedby perimeter surface 402, and optional groove 43, insulative bore 422forms a bonding zone for a sealing grommet, or septum, for use inconjunction with a standard set screw, according to constructions andmethods known in the art. In this case, depth d of flanged bore 360 ofcomponent 230 may extend up to approximately 0.06 inch (1.5 mm), sinceinsulative bore 422 need not accommodate the above-described sealingzone and optional groove 43. Insulative bore 422 is preferably entirelyformed by a single shot of insulative material, for example, by theabove described second shot, to prevent the potential formation ofdiscontinuities along the inner surface of bore 422, for example, at aninterface between core portion 260 and overlay portion 280, but may,according to alternate methods, be formed in two portions, for example,by the above-described first and second shots.

FIG. 6A is a flow chart outlining some methods of the present invention,with focus on the above-described ssb contact components 230. In aninitial step 61, a pin of a first type is positioned in each ssb contactcomponent 230. For example, with reference to FIG. 7A, each of pins 71,711 is a first type of pin, or core pin, positioned within the connectorbore of the corresponding ssb contact component 230, such that ashoulder 713 of each core pin 71, 711 abuts first face 31 (FIG. 3) ofthe corresponding component 230, and a tip of each pin 71, 711 extendsout through the opening of the corresponding connector bore 320 at thecorresponding third face 33. Next, per step 63, each contact component230, with the first type of pin inserted therein, is mounted in awelding fixture, for example, along with components shown in FIG. 2A, inparticular, a corresponding electrical component having contactinterfaces (i.e. component 200 with interfaces 220) that aresubsequently coupled to contact components 230, for example, by laserwelding, according to methods known in the art, per step 65.

According to some preferred methods, mounting each contact component 230involves securing each inserted pin of the first type to the fixture,for example, by a holding structure 701 shown in FIG. 7A, andpositioning flanged bore 260 of each ssb contact component 230 around acorresponding welding fixture pin, each of which is also secured to thefixture. For example, FIG. 7A shows flange bore 260 of each component230 positioned around a corresponding welding fixture pin 76, each ofwhich is supported by a block 705 that provides an interface forsecuring pins 76 to the welding fixture. Thus, ssb contact components230 are held in place, with respect to one another by pins 71, 76, whilecontact interfaces 220 of electrical component 200 (FIG. 2A) arepositioned and welded to each contact component, per step 65. Althoughnot shown in FIG. 7A, it should be understood that the welding fixturemay include a cradle or support structure, for example, similar to thatshown for mold tooling in FIG. 7B, in order to provide extra support forretaining all the components and pins in position, relative to oneanother, during welding, with a desired positional tolerance.

According to step 67 of FIG. 6A, when the welded assembly of ssb contactcomponents 230 and electrical component 200 are placed in a mold, aflanged bore of each contact component, for example, flanged bore 360(FIG. 3), is positioned around a pin of a second type, prior toinjecting insulative material to form the insulative body. According topreferred embodiments and methods, as described above, perimeter surface306 of each flanged bore 360 is a minimum slip-fit clearance fit aroundthe corresponding mold pin in order to create a shutoff, for example,wherein the mold pin extends at least approximately 0.01 inch (0.025 mm)into flanged bore 360. It should be noted that, in step 63, perimetersurface 306 of flanged bore 360 of each component 230 may also be aminimum slip-fit clearance fit around the corresponding welding fixturepin, for example, to hold a desired positional tolerance of contactcomponents 230 relative to one another during welding. Although,according to some methods, the insulative body of connector moduleassembly 115 may be wholly formed by a single shot of insulativematerial, per step 67, some preferred methods, as introduced above,employ a two stage molding process, alternatives of which are describedin greater detail in conjunction with FIGS. 6B, 7B-D and 8.

According to steps 661 and 681 of FIG. 6B, and with reference to FIGS.7B-C, each contact component, for example, ssb contact components 230,and each electrical component, for example, components 200 and 270, arepositioned in a core mold 750 for a first stage of molding that formscore portion 260 of the connector module insulative body, per step 671.With reference to FIGS. 7B-C, it should be noted that core pins 71, 711of the first type, which were previously positioned for welding, perstep 65 described above, remain positioned within the connector bores ofthe contact components in mold 750 for the formation of insulativeconnector bores in the first stage of molding. However, according toalternate methods, different core pins may be inserted into contactcomponent connector bores for molding. FIG. 7B illustrates feedthroughinterface panel portion 290, 297 of each electrical component 200, 270placed against a first surface of core mold 750, and an arrow Bindicating the direction in which a second surface of a second part (notshown) of core mold 750 will face, when positioned against panelportions 290, 297, to mount portions 290, 297 between the two surfaces,per step 681.

FIG. 7B further illustrates elongate finger-like portions 23, 20 ofelectrical component 200 and elongate finger-like portion/antenna 207 ofcomponent 270 extending into a cavity 75 of mold 750 such that a firstside of each touches another side of mold 750. With reference to FIG.7C, a surface 751 of mold 750 is indicated, along with a first side207-1 of antenna 207 that touches surface 751. Furthermore, a first side23-1 of several of elongate finger-like portions 23 is indicated, and itshould be understood that another surface of the second part of mold750, which is not shown, will touch sides 23-1, when the second part ismoved into place, for example, per arrow B of FIG. 7B. With reference toFIG. 7D, it can be seen that first side 207-1 of antenna 207, after coreportion 260 is formed, will be exposed in a cavity 77 of an overlay mold770.

FIG. 7C further illustrates the first set of contact interfaces 223 offinger-like portions 23 touching a surface of pin 71 in mold cavity 75,and, with reference back to FIG. 2A, it should be understood that thesecond set of contact interfaces 223 are touching a surface of the otherpin 71 which cannot be seen in FIG. 7C. According to the above-describedembodiments, following molding and the removal of core pins 71, contactinterfaces 223 are exposed within the insulative connector bores formedaround pins 71, for example, as can be seen in FIG. 8, so that contactcomponents, which are subsequently inserted into the bores 212, can becoupled to interfaces 223. With further reference to FIG. 7C, flangedbore 360 of one of ssb contact components 230 can be seen positionedaround a pin 72, per step 661, for example, so that pin 72 extends atleast approximately 0.01 inch (0.25 mm) into flanged bore 360. Accordingto some preferred embodiments and methods, as described above, perimetersurface 306 of flanged bore 360 of each ssb contact component 23 that isplaced in mold 750 is a minimum slip-fit clearance fit around thecorresponding pin 72 to create a shutoff for the subsequent injection ofthe first shot of insulative material, per step 671.

The first shot of insulative material, for example, which forms coreportion 260 of the insulative body of connector module assembly 115(FIGS. 2B and 8), is preferably a medical grade polyurethane (i.e.Lubrizol Thermedics™ Tecothane™ or Pellethane®) having a durometer ofapproximately 75 on a shore D scale. With further reference to FIG. 8,in conjunction with FIG. 3, an outer surface of core portion 260, inproximity to each flanged bore 360 of the corresponding component 230,is preferably approximately flush with opening 352 of flanged bore 360.FIG. 8 further illustrates core portion 260 of the insulative bodyhaving been formed with a flange feature 82 that extends about aperimeter of connector bore 121; feature 82 may also be seen in FIG. 2B.As described above, when connector bore 121 corresponds to a first typethat is different from bores 122, a color indicator 80 may be engagedwith feature 82, according to an optional step 691 of FIG. 6B, todistinguish bore 121 from the other bores 122 of the second type.According to embodiments that include indicator 80, overlay portion 280,which is formed per step 673, is translucent for viewing indicator 80therethrough. According to an exemplary embodiment of connector moduleassembly 115, connector bore 121 conforms to the IS-1 industry standard,while connector bores 122 conform to the IS-4 industry standard, both ofwhich standards are known to those skilled in the art of implantablemedical electrical devices.

According to the illustrated embodiment, optional indicator 80 is formedas a ring, from either a biocompatible polymer or metal, which ismounted around feature 82, yet, according to some alternate embodimentsand methods, optional indicator 80 may be a biocompatible ink, dye orpaint applied to a surface of feature 82. With reference back to FIG.4A, dashed lines represent an indicator, such as indicator 80, which isembedded in the insulative body of connector module assembly, forexample, between core portion 260 and overlay portion 280. According toadditional alternate embodiments, in lieu of flange feature 82, coreportion 260 may include a recessed feature formed in proximity to bore121, for example, a groove extending all or partway around the perimeterof bore 121, that is adapted to receive engagement of an optional colorindicator similar to any embodiment described above for indicator 80.For any type of indicator, the indicator is preferably engaged with afeature of core portion 260 so that the indicator can be viewed from anangle that is approximately perpendicular to a longitudinal axis of bore121, for example, as indicated by arrow A in FIG. 4A, although this neednot be the case in every connector module assembly embodiment. Thedescribed two-shot molding method is particularly useful forincorporating a color indicator, such as indicator 80, in a connectormodule assembly, so, according to some alternate embodiments andmethods, step 681, as well as steps 661 and 663, may be omitted.

With reference back to FIGS. 6B and 7B, core assembly 26 which is formedby the first shot of insulative material and the components shown inFIG. 7B, for example, per steps 661, 681, 671, may then be positioned,with optional indicator 80, in overlay mold 770, for example asillustrated in FIG. 7D. Again, each core pin 71, 711 may still remainpositioned within the connector bores of the contact components inoverlay mold 770. FIG. 7D illustrates elongate finger-like portions 20,23 of component 200 and elongate finger-like portion/antenna 207 ofcomponent 270 being captured in rigid relation to core portion 260 ofthe insulative body, and having sides exposed in cavity 77 of mold 770so that the second shot of injected insulative material will formoverlay portion 280 of the insulative body, per step 673, over all or aportion of the exposed sides, for example, as shown in the boxed area ofFIG. 7D. It should be noted, that, like for core mold 750 shown in FIG.7B, a second part of overlay mold 770 is not shown in FIG. 7D, and thatsurfaces of the second part of overlay mold 770 will touch first sides23-1 of elongate finger-like portions 23 in the area of contactinterfaces 223 in order to form apertures 213 in overlay portion 280,according to the embodiment described above, in conjunction with FIG.2C, and shown again in the boxed area of FIG. 7D. The described two-shotmolding method is particularly useful to maintain control over theplacement of elongate and relatively flexible parts, such as an entiretyof antenna 207, relative to other components in a connector moduleassembly; so, according to some alternate embodiments and methods, step691, as well as steps 661 and 663, may be omitted.

According to step 663, positioning core assembly 26 in mold 770 againinvolves positioning flanged bore 360 of each ssb contact component 23around a pin in overlay mold 770, for example, a pin 73 of a third typeshown in cross-section in FIG. 7D, wherein each pin 73 extendsapproximately 0.01 inch into the corresponding flanged bore 360, andeach flanged bore 360 is a minimum slip-fit clearance fit around thecorresponding pin 73 to create a shutoff for the subsequent second shotinjection of insulative material, per step 673. FIG. 7D illustrates alength of pin 73 exposed within mold cavity 77 to allow an insulativebore, for example, insulative bore 422 shown in FIGS. 4A-B, to be formedin overlay portion 280, by the second shot of insulative material. FIG.7D further illustrates an optional protrusion 703 along a profile of pin73, which forms the above-described optional groove 43 in insulativebore 422, which can be seen in FIGS. 4B and 5. When this two-stagemolding process is employed, insulative bore 422 is preferably entirelyformed by the second shot of insulative material, to prevent thepotential formation of discontinuities along the inner surface of bore422, that may arise at an interface between core portion 260 and overlayportion 280. The second shot of insulative material is preferably amedical grade polyurethane (i.e. Lubrizol Thermedics™ Tecothane™ orPellethane®) having a durometer of approximately 75 on a shore D scale.

Although molding in two stages may be preferred for forming connectormodule assemblies, like assembly 115, that include antenna 207 and/orcolor indicator 80, as described above, alternate methods can employ asingle shot molding operation to form an insulative body of a connectormodule assembly that includes ssb contact components 230, whichinsulative body includes the above-described connector bores 121, 122and insulative bores 422. In either case, the engagement of flanged bore360 of each ssb contact component 230 with the corresponding mold pinallows each insulative bore 422 to be formed in alignment with threadedbore 340 of the corresponding component 230, and prevents the flow ofplastic into the threads of the corresponding threaded bore 340 in animproved fashion over the aforementioned prior art methods that employmore time consuming and tedious processes to engage threads and/or makecritical alignment, with sufficient pressure, to provide shutoff duringmolding.

In the foregoing detailed description, the invention has been describedwith reference to specific embodiments. However, it may be appreciatedthat various modifications and changes can be made without departingfrom the scope of the invention as set forth in the appended claims.

1. A method for forming a connector module assembly for an implantablemedical device, the method comprising: mounting a feedthrough interfacepanel portion of an electrical component of the connector moduleassembly between opposing surfaces of a core mold such that an elongatefinger-like portion of the component extends into a cavity of the coremold, the elongate finger-like portion having a first side and a second,opposite side, the first side touching another surface of the core moldand the second side exposed within the cavity of the core mold; forminga core portion of an insulative body of the connector module assembly byinjecting a first shot of an insulative material into the cavity of thecore mold, after mounting the panel portion of the electrical component,the formed core portion of the insulative body extending over at least aportion of the second side of the elongate finger-like portion of theelectrical component and capturing the elongate finger-like portion inrelatively rigid relation thereto; placing the core portion of theinsulative body and the captured electrical component in a cavity of anoverlay mold such that at least a portion of the first side of theelongate finger-like portion of the component is exposed within thecavity of the overlay mold; and forming an overlay portion of theinsulative body of the connector module assembly by injecting a secondshot of insulative material into the cavity of the overlay mold, afterplacing the core portion and the captured electrical component, theformed overlay portion of the insulative body extending over all or aportion of the first side of the elongate finger-like portion.
 2. Themethod of claim 1, wherein the elongate finger-like portion of theelectrical component comprises an antenna and the overlay portion isformed to extend over all of the first side thereof.
 3. The method ofclaim 1, wherein the elongate finger-like portion of the electricalcomponent comprises a contact interface.
 4. The method of claim 3,further comprising coupling the contact interface to a contact componentcontained within a connector bore formed in the core portion of theinsulative body, after forming the overlay portion of the insulativebody; wherein the overlay portion is formed with an aperture providingaccess to the contact interface for the coupling thereof.
 5. The methodof claim 4, further comprising: positioning a core pin in the cavity ofthe core mold, prior to forming the core portion of the insulative body,in order to form the connector bore in the core portion and such thatthe contact interface of the elongate finger-like portion of theelectrical component touches a surface of the positioned core pin;removing the core pin from within the formed connector bore, afterforming the overlay portion of the insulative body, the core pin havingbeen placed, along with the core portion and the captured electricalcomponent, in the cavity of the overlay mold; and inserting the contactcomponent into the connector bore of the core portion of the insulativebody, for containment therein, after removing the core pin, thecontained contact component being located adjacent to the contactinterface of the electrical component.
 6. The method of claim 3, furthercomprising: coupling the contact interface of the electrical componentto a contact component, prior to mounting the panel portion of theelectrical component; mounting the contact component on a first, corepin such that a connector bore of the contact component extends aroundthe first, core pin, prior to forming the core portion of the insulativebody; positioning a flanged bore of the contact component around asecond pin in the core mold, prior to forming the core portion of theinsulative body, the flanged bore being in fluid communication with theconnector bore, and a perimeter surface of the positioned flanged borebeing a minimum slip fit clearance fit around the second pin to create ashutoff; and after forming the core portion and prior to forming theoverlay portion of the insulative body, positioning the flanged bore ofthe contact component around a third pin in the overlay mold, aperimeter surface of the positioned flanged bore being a minimumslip-fit clearance fit around the third pin to create a shutoff; whereinthe overlay portion includes an opening located at an outer surfacethereof and having been formed around the third pin, for passage intothe flanged bore of the contact component.
 7. The method of claim 6,wherein the overlay portion further includes an insulative bore thatextends from the opening of the overlay portion to the flanged bore ofthe contact component, the insulative bore having been formed around thethird pin and including a perimeter surface flush with the perimetersurface of the flanged bore of the contact component.
 8. The method ofclaim 7, wherein the third pin includes a protrusion along a profilethereof to create a groove about a perimeter of the insulative bore thatis formed around the third pin, the groove being located in proximity tothe opening at the outer surface of the overlay portion.
 9. The methodof claim 1, further comprising: positioning a first, core pin and asecond, core pin in the cavity of the core mold, prior to forming thecore portion of the insulative body, such that the core portion isformed with a connector bore of a first type, corresponding to the firstpin, and a connector bore of a second type, corresponding to the secondpin; and engaging a color indicator with a feature of the core portionof the insulative body, prior to forming the overlay portion of theinsulative body, the feature being located in proximity to the connectorbore of the first type; wherein the first and second core pins and thecolor indicator are placed, along with the core portion and the capturedelectrical component, in the overlay mold; and the overlay portion ofthe insulative body extends over the engaged color indicator and istranslucent for viewing the color indicator therethrough.
 10. The methodof claim 9, wherein the feature of the core portion extends about aperimeter of the connector bore of the first type.
 11. The method ofclaim 10, wherein the feature comprises a flange of the connector boreof the first type, and the color indicator is engaged on an outersurface thereof.
 12. The method of claim 9, wherein the color indicatoris engaged with the feature of the core portion such that the indicatorcan be viewed from an angle that is approximately perpendicular to alongitudinal axis of the connector bore of the first type.
 13. A methodfor forming a connector module assembly for an implantable medicaldevice, the method comprising: positioning a first core pin and a secondcore pin in a cavity of a core mold; forming a core portion of aninsulative body of the connector module assembly by injecting a firstshot of insulative material into the cavity of the core mold, afterpositioning the first and second core pins, such that the core portionis formed with a connector bore of a first type, corresponding to thefirst pin, and a connector bore of a second type, corresponding to thesecond pin; engaging a color indicator with a feature of the formed coreportion, the feature being located in proximity to the connector bore ofthe first type; and placing the core portion of the insulative body, thefirst and second core pins and the engaged color indicator in a cavityof an overlay mold; and forming an overlay portion of the insulativebody of the connector module assembly by injecting a second shot ofinsulative material into the cavity of the overlay mold, after placingthe core portion, the first and second core pins and the engaged colorindicator, the formed overlay portion extending over the engaged colorindicator and being translucent for viewing the color indicatortherethrough.
 14. The method of claim 13, wherein the feature of thecore portion extends about a perimeter of the connector bore of thefirst type.
 15. The method of claim 13, wherein the feature comprises aflange of the connector bore of the first type and the color indicatoris engaged on an outer surface of the flange.
 16. The method of claim13, wherein the color indicator is engaged with the feature of the coreportion such that the indicator can be viewed from an angle that isapproximately perpendicular to a longitudinal axis of the connector boreof the first type.
 17. The method of claim 13, further comprising:coupling a contact interface of a first of a plurality of elongatefinger-like portions of an electrical component to a first contactcomponent of the connector module assembly, the first contact componentbeing mounted on the first core pin such that a connector bore of thefirst contact component extends around the first core pin; mounting afeedthrough interface panel portion of the electrical component of theconnector module assembly between opposing surfaces of the core mold,prior to forming the core portion of the insulative body, such that theplurality of elongate finger-like portions of the electrical componentextend into the cavity of the core mold and a contact interface of asecond of the plurality of elongate finger-like portions touches asurface of the positioned second core pin; removing the first and secondcore pins from within the formed connector bores, after forming theoverlay portion of the insulative body; inserting a second contactcomponent into the connector bore of the second type, for containmenttherein, after removing the core pins, the contained second contactcomponent being located adjacent to the contact interface of theelectrical component; and coupling the contact interface of the secondelongate finger-like portion of the electrical component to thecontained second contact component; wherein the overlay portion isformed with an aperture providing access to the contact interface of thesecond elongate finger-like portion for the coupling thereof.
 18. Themethod of claim 17, further comprising: positioning a flanged bore ofthe first contact component around a third pin in the core mold, priorto forming the core portion of the insulative body, the flanged borebeing in fluid communication with the connector bore of the firstcontact component, and a perimeter surface of the positioned flangedbore being a minimum slip-fit clearance fit around the third pin tocreate a shutoff; and positioning the flanged bore of the first contactcomponent around a fourth pin in the overlay mold, after forming thecore portion and prior to forming the overlay portion of the insulativebody, a perimeter surface of the positioned flanged bore being a minimumslip-fit clearance fit around the fourth pin to create a shutoff; andwherein the overlay portion includes an opening located at an outersurface thereof and having been formed around the fourth pin, forpassage into the flanged bore of the first contact component.
 19. Themethod of claim 18, wherein: the feature of the core portion extendsabout a perimeter of the connector bore of the first type; and the colorindicator is engaged with the feature of the core portion such that theindicator can be viewed from an angle that is approximatelyperpendicular to a longitudinal axis of the connector bore of the firsttype.
 20. The method of claim 13, further comprising: coupling a contactinterface of an elongate finger-like portion of an electrical componentto a contact component of the connector module assembly, the contactcomponent being mounted on the first core pin such that a connector boreof the contact component extends around the first core pin; mounting afeedthrough interface panel portion of the electrical component of theconnector module assembly between opposing surfaces of the core mold,prior to forming the core portion of the insulative body, such that theelongate finger-like portion of the electrical component extends intothe cavity of the core mold; positioning a flanged bore of the contactcomponent around a third pin in the core mold, prior to forming the coreportion of the insulative body, the flanged bore being in fluidcommunication with the connector bore of the contact component, and aperimeter surface of the positioned flanged bore being a minimumslip-fit clearance fit around the third pin to create a shutoff; andpositioning the flanged bore of the contact component around a fourthpin in the overlay mold, after forming the core portion and prior toforming the overlay portion of the insulative body, a perimeter surfaceof the positioned flanged bore being a minimum slip fit clearance fitaround the fourth pin to create a shutoff; and wherein the overlayportion includes an opening located at an outer surface thereof andhaving been formed around the fourth pin, for passage into the flangedbore of the contact component.